Chronic Obstructive Pulmonary DiseasePhase 4NCT00316992
Safety of Ramelteon in Subjects With Chronic Obstructive Pulmonary Disease
A Phase 4 study of Chronic Obstructive Pulmonary Disease, run by Takeda at 8 sites in United States.
Trial summary
The purpose of this study is to determine if ramelteon has respiratory depressant effects in subjects with moderate to severe chronic obstructive pulmonary disease. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 8 sitesUnited States
- Study dates
- Apr 2006to Nov 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
- Body mass index between 18 and 34, inclusive.
- Clinical history of chronic obstructive pulmonary disease and a confirmatory diagnosis based on pulmonary function tests performed at the Outpatient Screening Visit, with moderate to severe airflow limitation defined by: Moderate: forced expiratory volume in one second to forced vital capacity less than 70%; 50% less than forced expiratory volume in one second; less than 80% predicted. Severe: forced expiratory volume in one second to forced vital capacity less than 70%; forced expiratory volume in one second less than 50% predicted.
- Post-bronchodilator forced expiratory volume in one second change from baseline of less than12% and not exceeding 200 ml at the Outpatient Screening Visit.
- Oxygen saturation during wakefulness greater than 90% (both supine and sitting) as assessed by pulse oximetry at the Outpatient Screening Visit.
- Oxygen saturation during sleep of greater than or equal to 80% for at least 75% of the recording period with no more than 5 continuous minutes less than 80% and with no oxygen saturation readings less than 70% as assessed by pulse oximetry at the Inpatient Screening Visit.
Who cannot join
- The health of subjects using nocturnal oxygen therapy would, in the investigator's opinion, be jeopardized by the removal of oxygen therapy during inpatient study visits.
- Electrocardiographic evidence of right ventricular hypertrophy, or evidence of right heart failure.
- Apnea hypopnea index (per hour of sleep) greater than 15 during polysomnography.
- Has had an acute clinically significant illness within two weeks or has been hospitalized within four weeks of the Outpatient Screening Visit.
- History of seizures (except childhood febrile seizures).
- History of cancer, other than basal cell carcinoma, that has not been in remission for at least five years prior to the first dose of study drug. (This criterion does not include those subjects with basal cell or Stage 1 squamous cell carcinoma of the skin.)
Show all 32Show fewer
- History of drug addiction or drug abuse within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised.
- History of alcohol abuse within the past 12 months, as defined in
- Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised and/or regularly consumes more than 14 alcoholic drinks per week, or consumed any alcoholic drinks within six hours of any PSG visits.
- Will not refrain from use of tobacco products while in the sleep laboratory.
- Any clinically important abnormal finding, other than chronic obstructive pulmonary disease, as determined by medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator.
- Current significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic disease, unless currently controlled and stable with protocol-allowed medication 30 days prior to the Inpatient Screening Visit.
- Hematocrit value greater than 55% at the Outpatient Screening Visit.
- Positive hepatitis panel including anti-hepatitis A virus (only immunoglobulin M is exclusionary), hepatitis B surface antigen, or anti-hepatitis C virus.
- Alanine transaminase level of greater than three times the upper limit of normal, active liver disease, jaundice or any clinically significant abnormal laboratory findings as determined by the investigator.
- Donated more than 400 mL of blood within the 90 days preceding the beginning of the study.
- Positive urine drug screen for drugs known to alter sleep-wake function (eg, barbiturates, opiates, amphetamines, cannabinoids and alcohol) at screening, or a positive breathalyzer test for alcohol at any check-in.
- Known hypersensitivity to ramelteon or related compounds, including melatonin.
- Known hypersensitivity to albuterol or related compounds.
- Participated in any other investigational study and/or taken any investigational drug within 30 days or five half-lives prior to the first dose of single-blind study medication, whichever is longer.
- Unable to discontinue the use of hypnotics for the duration of the study.
- Has used melatonin, or other drugs or supplements known to affect sleep-wake function, within one week (or five half-lives of the drug, whichever is longer) prior to the first dose of single-blind study medication.
- Any additional condition(s) that in the Investigator's opinion would prohibit the subject from completing the study or not be in the best interest of the subject.
- Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
- Within one week of single-blind medication and during the entire study.
- Hypnotics
- Sedating Antidepressants
- Sedating H1 antihistamines
- Respiratory stimulants
- Muscle relaxants
- The use of albuterol is acceptable during reversibility testing at the Outpatient Screening Visit.
- Melatonin and all other drugs or supplements known to affect sleep/wake function will be prohibited within one week of the first dose of single-blind medication and during the entire study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Study site
Birmingham, Alabama, 35213
Study site
Lincoln, Nebraska, 68510
Study site
Los Angeles, California
Study site
Louisville, Kentucky, 40217
Study site
Naples, Florida, 34110
Study site
New York, New York, 10025
Study site
Santa Monica, California, 90404
Study site
St. Petersburg, Florida, 33707
About this study
Official title: A Study of the Safety of Ramelteon in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease
The purpose of this study is to determine if ramelteon has respiratory depressant effects in subjects with moderate to severe chronic obstructive pulmonary disease.
Read the detailed description
About 30% of the adult population report sleep disturbance and 10% meet diagnostic criteria for chronic insomnia. While 20 -25% of these individuals have primary insomnia the vast majority have an additional condition such as chronic obstructive pulmonary disease. Several studies have looked at this and have estimated that 30% to 48% of the general population is affected at some time in their life with a form of insomnia that goes on for several months, and about one third of those are described as severely affected. Daytime symptoms of insomnia include tiredness, lack of energy, difficulty concentrating and irritability. Recent epidemiologic research focusing on the quality of life has identified significant insomnia related conditions or diseases that relate to work productivity, health care utilization, and risk of depression. Insomnia is associated with diminished work output, absenteeism and greater rates of accidents.
Ramelteon, is being developed as a sleep promoting agent based on agonism of melatonin receptor subtype 1 and 2. Ramelteon is marketed in the United States as Rozerem™ for the treatment of insomnia characterized by difficulty with sleep initiation.
Sleep problems are common in patients with chronic obstructive pulmonary disease. There is evidence that traditional hypnotics can cause adverse respiratory effects in insomniac populations with respiratory disorders, and so the safety and efficacy of new hypnotic agents must be ascertained in this group of patients.
This study will examine if ramelteon has respiratory depressant effects in subjects with moderate to severe chronic obstructive pulmonary disease. Study participation is anticipated to be about 6 weeks.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Ramelteon and Placebo
- Keywords
- Insomnia, Chronic Obstructive Pulmonary Disease, Drug Therapy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ramelteon and PlaceboDrug
Also called Rozerem™, TAK-375
Ramelteon 8 mg, tablets, orally, one night only and Ramelteon placebo-matching tablets, orally, one night only.
| Study group | Role | What they receive |
|---|---|---|
| Ramelteon 8 mg and Placebo | Experimental | Not described Receives: Drug: Ramelteon and Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean oxygen saturation during sleep for the entire night measured by pulse oximetry.
Measured: Crossover Period 1 Night 1 and Crossover Period 2 Night 1
Secondary outcomes (20)
Mean oxygen saturation calculated for each hour of the night, as measured by pulse oximetry.
Measured: Crossover Period 1 Night 1 and Crossover Period 2 Night 1
Mean oxygen saturation for rapid eye movement sleep stages, as measured by pulse oximetry.
Measured: Crossover Period 1 Night 1 and Crossover Period 2 Night 1
Mean oxygen saturation for non- rapid eye movement sleep stages, as measured by pulse oximetry.
Measured: Crossover Period 1 Night 1 and Crossover Period 2 Night 1
Minutes for which oxygen saturation was less than 80% as measured by pulse oximetry.
Measured: Crossover Period 1 Night 1 and Crossover Period 2 Night 1
Minutes for which oxygen saturation was less than 90% as measured by pulse oximetry.
Measured: Crossover Period 1 Night 1 and Crossover Period 2 Night 1
Apnea-hypopnea index as determined by polysomnography.
Measured: Crossover Period 1 Night 1 and Crossover Period 2 Night 1
Latency to persistent sleep as determined by polysomnography.
Measured: Crossover Period 1 Night 1 and Crossover Period 2 Night 1
Total sleep time as determined by polysomnography.
Measured: Crossover Period 1 Night 1 and Crossover Period 2 Night 1
Sleep efficiency as determined by polysomnography.
Measured: Crossover Period 1 Night 1 and Crossover Period 2 Night 1
Wake time after persistent sleep onset as determined by polysomnography.
Measured: Crossover Period 1 Night 1 and Crossover Period 2 Night 1
Number of awakenings after persistent sleep as determined by polysomnography.
Measured: Crossover Period 1 Night 1 and Crossover Period 2 Night 1
Percentage of time in rapid eye movement sleep as determined by polysomnography.
Measured: Crossover Period 1 Night 1 and Crossover Period 2 Night 1
Percentage of time in stage 1 sleep as determined by polysomnography.
Measured: Crossover Period 1 Night 1 and Crossover Period 2 Night 1
Percentage of time in stage 2 sleep as determined by polysomnography.
Measured: Crossover Period 1 Night 1 and Crossover Period 2 Night 1
Percentage of time in stage 3/4 sleep as determined by polysomnography.
Measured: Crossover Period 1 Night 1 and Crossover Period 2 Night 1
Latency to rapid eye movement sleep as determined by polysomnography.
Measured: Crossover Period 1 Night 1 and Crossover Period 2 Night 1
Subjective sleep latency as determined by postsleep questionnaire.
Measured: Crossover Period 1 Morning 1 and Crossover Period 2 Morning 1
Subjective total sleep time as determined by postsleep questionnaire.
Measured: Crossover Period 1 Morning 1 and Crossover Period 2 Morning 1
Subjective Sleep Quality as determined by postsleep questionnaire.
Measured: Crossover Period 1 Morning 1 and Crossover Period 2 Morning 1
Subjective number of awakenings as determined by postsleep questionnaire.
Measured: Crossover Period 1 Morning 1 and Crossover Period 2 Morning 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Director Clinical Science, Study director, Takeda Global Research and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00316992
- Sponsor's protocol ID
- 01-05-TL-375-068
- Other IDs
- U1111-1115-1960
- Status last verified
- May 2010
- First submitted
- 19 Apr 2006
- Last updated
- 2 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Kryger M, Roth T, Wang-Weigand S, Zhang J. The effects of ramelteon on respiration during sleep in subjects with moderate to severe chronic obstructive pulmonary disease. Sleep Breath. 2009 Mar;13(1):79-84. doi: 10.1007/s11325-008-0196-4. Epub 2008 Jun 27.
PubMed 18584227
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Safety of Ramelteon in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00316992
- Acronym / sponsor ID
- 01-05-TL-375-068
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Insomnia, Chronic Obstructive Pulmonary Disease, Drug Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 21 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if ramelteon has respiratory depressant effects in subjects with moderate to severe chronic obstructive pulmonary disease.
Detailed description
About 30% of the adult population report sleep disturbance and 10% meet diagnostic criteria for chronic insomnia. While 20 -25% of these individuals have primary insomnia the vast majority have an additional condition such as chronic obstructive pulmonary disease. Several studies have looked at this and have estimated that 30% to 48% of the general population is affected at some time in their life with a form of insomnia that goes on for several months, and about one third of those are described as severely affected. Daytime symptoms of insomnia include tiredness, lack of energy, difficulty concentrating and irritability. Recent epidemiologic research focusing on the quality of life has identified significant insomnia related conditions or diseases that relate to work productivity, health care utilization, and risk of depression. Insomnia is associated with diminished work output, absenteeism and greater rates of accidents.
Ramelteon, is being developed as a sleep promoting agent based on agonism of melatonin receptor subtype 1 and 2. Ramelteon is marketed in the United States as Rozerem™ for the treatment of insomnia characterized by difficulty with sleep initiation.
Sleep problems are common in patients with chronic obstructive pulmonary disease. There is evidence that traditional hypnotics can cause adverse respiratory effects in insomniac populations with respiratory disorders, and so the safety and efficacy of new hypnotic agents must be ascertained in this group of patients.
This study will examine if ramelteon has respiratory depressant effects in subjects with moderate to severe chronic obstructive pulmonary disease. Study participation is anticipated to be about 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ramelteon 8 mg and Placebo | Experimental | Drug: Ramelteon and Placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
- Body mass index between 18 and 34, inclusive.
- Clinical history of chronic obstructive pulmonary disease and a confirmatory diagnosis based on pulmonary function tests performed at the Outpatient Screening Visit, with moderate to severe airflow limitation defined by: Moderate: forced expiratory volume in one second to forced vital capacity less than 70%; 50% less than forced expiratory volume in one second; less than 80% predicted. Severe: forced expiratory volume in one second to forced vital capacity less than 70%; forced expiratory volume in one second less than 50% predicted.
- Post-bronchodilator forced expiratory volume in one second change from baseline of less than12% and not exceeding 200 ml at the Outpatient Screening Visit.
- Oxygen saturation during wakefulness greater than 90% (both supine and sitting) as assessed by pulse oximetry at the Outpatient Screening Visit.
Key exclusion criteria (32 listed)
- The health of subjects using nocturnal oxygen therapy would, in the investigator's opinion, be jeopardized by the removal of oxygen therapy during inpatient study visits.
- Electrocardiographic evidence of right ventricular hypertrophy, or evidence of right heart failure.
- Apnea hypopnea index (per hour of sleep) greater than 15 during polysomnography.
- Has had an acute clinically significant illness within two weeks or has been hospitalized within four weeks of the Outpatient Screening Visit.
- History of seizures (except childhood febrile seizures).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ramelteon and PlaceboAlso: Rozerem™, TAK-375Ramelteon 8 mg, tablets, orally, one night only and Ramelteon placebo-matching tablets, orally, one night only. | Drug | Ramelteon 8 mg and Placebo |
Primary outcome
Mean oxygen saturation during sleep for the entire night measured by pulse oximetry.
Time frame: Crossover Period 1 Night 1 and Crossover Period 2 Night 1
20 secondary outcomes
Mean oxygen saturation calculated for each hour of the night, as measured by pulse oximetry.
Time frame: Crossover Period 1 Night 1 and Crossover Period 2 Night 1
Mean oxygen saturation for rapid eye movement sleep stages, as measured by pulse oximetry.
Time frame: Crossover Period 1 Night 1 and Crossover Period 2 Night 1
Mean oxygen saturation for non- rapid eye movement sleep stages, as measured by pulse oximetry.
Time frame: Crossover Period 1 Night 1 and Crossover Period 2 Night 1
Minutes for which oxygen saturation was less than 80% as measured by pulse oximetry.
Time frame: Crossover Period 1 Night 1 and Crossover Period 2 Night 1
Minutes for which oxygen saturation was less than 90% as measured by pulse oximetry.
Time frame: Crossover Period 1 Night 1 and Crossover Period 2 Night 1
Apnea-hypopnea index as determined by polysomnography.
Time frame: Crossover Period 1 Night 1 and Crossover Period 2 Night 1
Latency to persistent sleep as determined by polysomnography.
Time frame: Crossover Period 1 Night 1 and Crossover Period 2 Night 1
Total sleep time as determined by polysomnography.
Time frame: Crossover Period 1 Night 1 and Crossover Period 2 Night 1
Sleep efficiency as determined by polysomnography.
Time frame: Crossover Period 1 Night 1 and Crossover Period 2 Night 1
Wake time after persistent sleep onset as determined by polysomnography.
Time frame: Crossover Period 1 Night 1 and Crossover Period 2 Night 1
Number of awakenings after persistent sleep as determined by polysomnography.
Time frame: Crossover Period 1 Night 1 and Crossover Period 2 Night 1
Percentage of time in rapid eye movement sleep as determined by polysomnography.
Time frame: Crossover Period 1 Night 1 and Crossover Period 2 Night 1
Percentage of time in stage 1 sleep as determined by polysomnography.
Time frame: Crossover Period 1 Night 1 and Crossover Period 2 Night 1
Percentage of time in stage 2 sleep as determined by polysomnography.
Time frame: Crossover Period 1 Night 1 and Crossover Period 2 Night 1
Percentage of time in stage 3/4 sleep as determined by polysomnography.
Time frame: Crossover Period 1 Night 1 and Crossover Period 2 Night 1
Latency to rapid eye movement sleep as determined by polysomnography.
Time frame: Crossover Period 1 Night 1 and Crossover Period 2 Night 1
Subjective sleep latency as determined by postsleep questionnaire.
Time frame: Crossover Period 1 Morning 1 and Crossover Period 2 Morning 1
Subjective total sleep time as determined by postsleep questionnaire.
Time frame: Crossover Period 1 Morning 1 and Crossover Period 2 Morning 1
Subjective Sleep Quality as determined by postsleep questionnaire.
Time frame: Crossover Period 1 Morning 1 and Crossover Period 2 Morning 1
Subjective number of awakenings as determined by postsleep questionnaire.
Time frame: Crossover Period 1 Morning 1 and Crossover Period 2 Morning 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2010.
- Results publication: PubMed 18584227Kryger M, Roth T, Wang-Weigand S, Zhang J. The effects of ramelteon on respiration during sleep in subjects with moderate to severe chronic obstructive pulmonary disease. Sleep Breath. 2009 Mar;13(1):79-84. doi: 10.1007/s11325-008-0196-4. Epub 2008 Jun 27.
- Rozerem Package InsertLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director Clinical Science study director
Takeda Global Research and Development
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Chronic Obstructive Pulmonary Disease, run by Takeda at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean oxygen saturation during sleep for the entire night measured by pulse oximetry. (time frame: Crossover Period 1 Night 1 and Crossover Period 2 Night 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00316992, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2010.